CTRI Number |
CTRI/2025/05/086495 [Registered on: 07/05/2025] Trial Registered Prospectively |
Last Modified On: |
06/05/2025 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Siddha |
Study Design |
Single Arm Study |
Public Title of Study
|
study on siddha medicine manjal noi kudineer for treating anemia in children |
Scientific Title of Study
|
An open clinical trial to evaluate the effectiveness of siddha herbal formulation Manjal noi kudineer for the management of Paandu noi (Iron Deficiency Anemia) in children among out-patients attending Ayothidass Pandithar Hospital, National Institute Of Siddha. |
Trial Acronym |
NIL |
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Dr N Sabana yasmine |
Designation |
PG SCHOLAR |
Affiliation |
Natioal Institute Of Siddha |
Address |
Room no 16/17, Department of Kuzhandhai Maruthuvam, National Institute Of Siddha, Tambaram Sanatorium,Chennai-47, kancheepuram.
Kancheepuram TAMIL NADU 600047 India |
Phone |
09600876457 |
Fax |
|
Email |
sabanayasmine2020@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr N Sabana yasmine |
Designation |
PG SCHOLAR |
Affiliation |
Natioal Institute Of Siddha |
Address |
Room no 16/17, Department of Kuzhandhai Maruthuvam, National Institute Of Siddha, Tambaram Sanatorium,Chennai-47, kancheepuram.
Kancheepuram TAMIL NADU 600047 India |
Phone |
09600876457 |
Fax |
|
Email |
sabanayasmine2020@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Dr K Suresh |
Designation |
Professor |
Affiliation |
Natioal Institute Of Siddha |
Address |
Room no 16/17, Department of Kuzhandhai Maruthuvam, National Institute Of Siddha, Tambaram Sanatorium,Chennai-47, kancheepuram.
Kancheepuram TAMIL NADU 600047 India |
Phone |
9962571137 |
Fax |
|
Email |
drsureshherbal@gmail.com |
|
Source of Monetary or Material Support
|
National Institute Of Siddha, Tambaram Sanatorium, Chennai-47 |
|
Primary Sponsor
|
Name |
National Institute of Siddha |
Address |
Room no 16/17, Department of Kuzhandhai Maruthuvam, National Institute Of Siddha,Tambaram Sanatorium, Chennai-47,Kancheepuram |
Type of Sponsor |
Research institution and hospital |
|
Details of Secondary Sponsor
|
|
Countries of Recruitment
|
India |
Sites of Study
|
No of Sites = 1 |
Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
Dr N Sabana yasmine |
Ayothidoss Pandithar Hospital |
Room no 16/17, Department of kuzhanthai Maruthuvam,National Institute of Siddha,
Tambaram Sanatorium,Chennai-47 Kancheepuram TAMIL NADU |
9600876457
sabanayasmine2020@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Institutional Ethics Committee |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: D509||Iron deficiency anemia, unspecified, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Intervention |
Manjal noi kudineer |
Adult dose 85 ml
For children dose will be given according to weight of the child using Clarks rule |
Comparator Agent |
Nil |
Nil |
|
Inclusion Criteria
|
Age From |
3.00 Year(s) |
Age To |
12.00 Year(s) |
Gender |
Both |
Details |
Hemoglobin level within 8.0-10.9gm |
|
ExclusionCriteria |
Details |
Patient with chronic disease
Known case of any hematological disorder |
|
Method of Generating Random Sequence
|
Not Applicable |
Method of Concealment
|
Not Applicable |
Blinding/Masking
|
Not Applicable |
Primary Outcome
|
Outcome |
TimePoints |
The clinical study will be assessed by increase of hemoglobin level in before and after treatment
For clinical significance defined as the MCID of hemoglobin increase from the baseline.
Reduction of clinical symptoms like malaise, headache, palpitation, lack of concentration during before and after treatment. |
18 months |
|
Secondary Outcome
|
Outcome |
TimePoints |
Reduction of clinical symptoms like malaise, headache, palpitation, lack of concentration during before and after treatment. |
18 months |
|
Target Sample Size
|
Total Sample Size="30" Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
Phase of Trial
|
Phase 2 |
Date of First Enrollment (India)
|
04/06/2025 |
Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
Date of First Enrollment (Global) |
Date Missing |
Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
Estimated Duration of Trial
|
Years="1" Months="6" Days="0" |
Recruitment Status of Trial (Global)
|
Not Applicable |
Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
|
N/A |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
|
BACKGROUND: Iron deficiency anemia (ICD -11:3A00, ISMT-4.7.40))
is a significant public health problem that occurs worldwide in both developed
and developing countries. In 1980, the World Health Organization (WHO)
estimated that 700 million people worldwide suffered from anemia and more than
two billion people worldwide have been affected by it. Approximately 50% of
anemia cases are caused by iron deficiency. Iron deficiency anemia (IDA) is
the most frequent hematological disorder of childhood and adolescence and the
most common form of anemia, with an incidence in industrialized countries of
20.1% between 0 and 4 years of age and 5.9% between 5 and 14 years (39 and48.1%
in developing countries) . It is a hypochromic and microcytic anemia
characterized by Hb values below the normal range for sex and age, reduced MCV,
and MCH. Iron is an essential nutrient for the development of the fetus,
infant, and child . The body’s iron content is dependent on its intake and
absorption with nutrition. The homeostasis of this nutrient is determined by
the balance between its uptake and release from the cells where it is stored
and recycled . Iron is released into the circulation where it is carried
by the plasma protein transferrin, into the duodenum by enterocytes that absorb
dietary iron, and by macrophages which recycle senescent erythrocytes and liver
reserves. If iron levels in the body are inadequate, its intestinal
absorption is enhanced [6]; In case of excess, it is stored in the enterocytes
as ferritin and the liver, spleen, and bone marrow as hemosiderin. The
release of free iron ions in the plasma, essential for the maintenance of its
homeostasis, is mediated by ferroportin, whose expression is subordinated to
the activity of hepcidin. WHO criteria for diagnosis of IDA: Age 6 months -
6 yrs: less than 11 gms, Age 6 yrs - 14 yrs : less than 12 gms. Mild:
Hemoglobin 10.0 g/dL to lower limit of normal. Moderate: Hemoglobin 8.0 to 10.9
g/dL. Severe: Hemoglobin 6.5 to 7.9 g/dL. According to the Siddhar Yugi muni
the diseases are widely classified into 4448 including Veluppu noi also. The
term Veluppu denots the pallor of the body. Veluppu is described as a diseased
condition in which the nature of the body including nail beds and conjunctiva
becomes pallor. As per siddha concept Veluppu noi occurs due to excessive
intake of salt and sour taste,fever, vomiting, diarrhoea, worms, liver diseases
and intake of unconsumed items such as soil,ash and camphor. Iron deficiency
causes different abnormalities in the three major population groups that are at
risk. In iron-deficient infants and children, there is convincing evidence of
impaired psychomotor development and cognitive.I have chosen siddha herbal
formulation –Manjal noi kudineer contains Keezhanelli (Phyllanthus
amarus,Shum&Thonn), karisalai (Eclipta prostrata,Linn), peipudal
(Trichosanthes cucumerina,Linn), venmilagu (Piper cubeba,Linn), Sombu
(Foeniculum vulgare,Mill), vilvam (Aegle marmelos,Linn). OBJECTIVE: PRIMARY
OBJECTIVE: • To evaluate the efficacy of Manjal noi kudineer in the management
of Paandu noi (IDA) in paediatric population.
OBJECTIVE: PRIMARY OBJECTIVE: • To evaluate the efficacy of
Manjal noi kudineer in the management of Paandu noi (IDA) in paediatric
population.
STUDY DESIGN: This is an interventional study of Non randomized
sampling which will be carried out for 18 months in patients with hemoglobin
level of 8.0-10.9 gm reporting at OPD of
Ayothidoss Pandithar Hospital , National Institute Of Siddha, Chennai-600047
with 30 patients as sample size. Patient with age 3-12 years of both sex.
OUTCOME: PRIMARY
OUTCOME:- • Primary outcome of the clinical study will be assessed by increase
of hemoglobin (Hb) level in before &after treatment. • For clinical
significance defined as the MCID of hemoglobin (Hb) increase from the baseline.
SECONDARY OUTCOME: Reduction of clinical symptoms like malaise, headache,
palpitation, lack of concentration during before and after treatment.
RESULT AND DISCUSSION: The result will be statistically
analysed and reported.
KEYWORDS: anemia, manjal noi kudineer, hemoglobin. |